# FDA 483 - Freethink Technologies, Inc. - February 21, 2024

Source: https://www.globalkeysolutions.net/records/483/freethink-technologies-inc/5345541a-b0bd-4725-934c-494b5fa20226

> FDA 483 for Freethink Technologies, Inc. on February 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Freethink Technologies, Inc.
- Inspection Date: 2024-02-21
- Product Type: drugs
- Office Name: New England District Office
- Summary: Freethink Technologies, Inc. in Branford, CT, a contract laboratory, was inspected by the FDA from February 12-21, 2024. The inspection revealed significant deficiencies in the firm's quality control unit procedures, including inadequate water system monitoring, insufficient stability chamber management, and a lack of a robust Corrective and Preventive Action (CAPA) system. These issues indicate a serious lack of control over critical quality processes.

## Related Officers

- [Deputy Director](https://www.globalkeysolutions.net/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)
- [Paige R. McCoy](https://www.globalkeysolutions.net/people/paige-r-mccoy/d871e1a3-ec99-4c8b-a12f-477d7719f09a)

Company: https://www.globalkeysolutions.net/companies/freethink-technologies-inc/00d34b6a-d1b9-4a3e-a22a-ba0e172b494e

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144